DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-2 filed June 08, 2023 are currently pending.
Priority
Acknowledgement is made of the national stage entry of PCT/JP2021/045475 filed 12/10/2021 which claims foreign priority to Application 2020-206109 filed 12/11/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/08/2023 and 05/09/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter (the pending claims are drawn to composition comprising a medium chain fatty acid which is known to be a natural product, and the claim as a whole does not recite something significantly different than the judicial exception itself).
The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because medium chain fatty acids are naturally occurring compounds. See the prior art of “Caprylic acid: WebMD published 2017) rejections below. As evidenced by paragraph [0015] of the specification, the species capric acid (C10) and caprylic acid (C8) lie within the genus of medium chain fatty acid found within the present claims.
According to Memorandum entitled, “Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products,” published online on March 4, 2014 (hereinafter "Guidance”). The Guidance establishes a three step inquiry to determine whether the claim is drawn to patent-eligible subject matter and should be rejected under 35 USC §101 as not being drawn to patent-eligible subject matter. The first inquiry is whether the claimed invention is directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter.
The second inquiry is whether the claim recites or involves one or more judicial exceptions. As described in MPEP § 2106, judicial exceptions includes abstract ideas, laws of nature/natural principles, natural phenomena, and natural products wherein these judicial exceptions reflect the judicial view that these fundamental tools of scientific and technological work are not patentable.
The third inquiry asks whether the claim as a whole recites something significantly different than the judicial exception(s). If the claims recites or involves a judicial exception such as a law of nature/natural principle or natural phenomenon, and/or something that appears to be a natural product, then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself. The Guidance notes that a significant difference can be shown in multiple ways, such as: (1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrates that the claimed subject matter is markedly different from what exists in nature. Moreover, the Guidance provides factors in aiding in the determination of whether claimed subject matter is markedly different from what exists in nature wherein the totality of the relevant factors weigh toward eligibility or ineligibility. It is noted that not all factors may be relevant for a particular invention.
Factors that weigh in favor of eligibility (i.e., claimed subject matter is significantly different): a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products; b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s); c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s); d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s); e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application and f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.
Factors that weigh against eligibility include the following (i.e., claimed subject matter is NOT significantly different): g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products; h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered; i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s); j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field; k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s) and l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.
In the instant case, claims 1-2 are drawn to a composition comprising medium chain fatty acids. The claimed subject matter is NOT significantly different than the judicial exception as the claims are product claims reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products. See the prior art of Lemarie et al., (Biochemie Vol. 120 pages 40-48. Published 2016; abstract, page 41 left col. ). The recitation of “medium chain fatty acid” is at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered. Further, the claims recite the intended use of the medium chain fatty acid for the treatment of aortic aneurysm.
In evaluating the third inquiry with respect to whether the claims as a whole recites something significantly different than the judicial exception, there are three factors (factors g, h and l) that weigh against patent eligibility. As discussed above, factors g h and l weigh against patent eligibility as the claims are product claims reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products, recited in a high level of generality such that substantially all practical applications of the judicial exception(s) are covered and nothing more than a mere field of use. Thus, in weighing the totality of the factors, the presently claimed invention is deemed patent ineligible subject matter. Therefore, in evaluating the totality of the relevant factors weighing against patent ineligibility the presently claimed invention is NOT markedly different from the judicial exception.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kugo (Bioscience, Biotechnology and Biochemistry Vol. 80 pages 1186-1191 published 2016).
Claim interpretation is as follows: Claim 1 is directed to a pharmaceutical composition for treating an aortic aneurysm, comprising a medium chain fatty acid as an active component. Claim 2 is directed to a processed food for treating an aortic aneurysm, comprising a medium chain fatty acid as an active component.
Applicant is reminded of MPEP 2111.03 wherein the transitional phrase “comprising” is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In the present case, the pharmaceutical composition or processed food composition comprising a medium chain fatty acid does not exclude additional unrecited elements such as eicosapentaenoic acid and docosahexaenoic acid.
Kugo teaches administration of a nutritional food containing coconut oil composed of 7% of the medium chain fatty acid caprylic acid and 7% of the medium chain fatty acid capric acid combination with the fish oils eicosapentaenoic acid and docosahexaenoic acid is efficacious at suppressing aortic dilation and preventing the development of an aortic aneurysm in a subject in need (abstract, pages 1187-1188, Table 1).
As evidenced by paragraph [0015] of the specification, the species capric acid (C10) and caprylic acid (C8) lie within the genus of medium chain fatty acid found within the present claims. As evidenced by [0028], the administration of the nutritional food coconut oil composed of 7% caprylic acid and 7% capric acid in combination with the fish oils eicosapentaenoic acid and docosahexaenoic acid reads on the presently claimed “processed food”. The composition containing coconut oil composed of 7% of the medium chain fatty acid caprylic acid and 7% of the medium chain fatty acid capric acid further contains the pharmaceutically acceptable excipients of cellulose and cornstarch, which reads on the presently claimed pharmaceutical composition.
Regarding the claimed limitation directed to the use of the nutritional food containing coconut oil composed of 7% of the medium chain fatty acid caprylic acid and 7% of the medium chain fatty acid capric acid in combination with the fish oils eicosapentaenoic acid and docosahexaenoic for the treatment of an aortic aneurysm such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed composition as treatment for an aortic aneurysm), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble of not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP §2112.02(11).
In the instant case, the cited prior art nutritional food of coconut oil composed of 7% caprylic acid and 7% capric acid in combination with the fish oils eicosapentaenoic acid and docosahexaenoic meets each and every structural and physical limitation of the instantly claimed composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 17620406 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of copending Application 17620406 are drawn to a composition for preventing an aortic aneurysm comprising caprylic acid or capric acid or a glyceride including capric or caprylic acid, while the present claims are directed to a pharmaceutical composition for treating an aortic aneurysm comprising a medium chain fatty acid. As evidenced by paragraph [0015] of the specification, the species capric acid (C10) and caprylic acid (C8) lie within the genus of medium chain fatty acid found within the present claims and thus, the composition within claims 1-20 of copending Application 17620406 anticipates the presently claimed composition.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GEORGE W KOSTURKO/Examiner, Art Unit 1621